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The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.
Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-2102 | Experimental | NVP-2102 |
|
| NVP-2102-R | Active Comparator | NVP-2102-R |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-2102 | Drug | Tablet formulation for oral administration, single dose of NVP-2102 at Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Area under the plasma drug concentration-time curve(AUCt) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Evaluation of Maximum observed plasma concentration(Cmax) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Evaluation of AUCt/AUC∞ | Pharmacokinetics parameter derived from plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Woo Kim | H+ Yangji hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | Nambusunhwan-ro | 08779 | South Korea |
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| NVP-2102-R |
| Drug |
Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1 |
|
| 0 ~ 72 hours |
| Evaluation of Time of peak concentration(Tmax) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Evaluation of Terminal phase of Half-life(t1/2) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Evaluation of total clearance of the drug from plasma after oral administration(CL/F) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |
| Evaluation of volume of distribution after non-intravenous administration(Vz/F) | Pharmacokinetics parameter derived from plasma | 0 ~ 72 hours |